CompliancePal: regulatory compliance with every commit

Presentation and demo at Healthtech Finland RA1 about CompliancePal approach to perform medical device software development regulatory activities at the same pace as the development team.

Transcript

1. CompliancePal Regulatory compliance with every commit Vlad Stirbu Healthtech Finland RA1 28.04.2020
2. Who am I? Vlad Știrbu CompliancePal Nokia PhD Software Systems (TUT)
3. Development in a software intensive world rigid flexible comprehensive informal Agile Waterfall DevOps DepOps++ CompliancePal @VladStirbu
4. Medical Consumer Reliable Long-life Regulated Hardware Design Disposable Agile Software CompliancePal @VladStirbu
5. Medical Consumer Reliable Long-life Regulated Hardware Design Disposable Agile Software CompliancePal @VladStirbu
6. Modern agile CompliancePal @VladStirbu
7. “Documentation is not real work.” (not to be named) Lead Front-End Developer CompliancePal @VladStirbu
8. What about conformance? Medical Device v1.0 CompliancePal @VladStirbu
9. What does the marking mean? • Legislation (EU) ◦ Medical Device Directive ◦ Medical Device Regulation (from 05/2021) • ISO technical standards ◦ 13485 - quality management ◦ 14971 - risk management ◦ 62304 - software development life cycle CompliancePal @VladStirbu
10. ISO 62304: Medical software development life cycle CompliancePal @VladStirbu
11. Modern agile meets regulated environments CompliancePal Requirements Wikis Commits Configurations Tests Containers Deployments @VladStirbu
12. https://twitter.com/rsiilasmaa/status/849940433358778369 CompliancePal @VladStirbu
13. Reality of agile meets regulated environments CompliancePal @VladStirbu
14. CompliancePal Photo by Jeffrey Coolidge/Iconica/Getty Images @VladStirbu code iterations programming languages configurations deployment environments
15. Automated medical software compliance CompliancePal Compliance Officers ➔ Take care of regulations ➔ FDA, MDR ➔ ISO 14971, ISO 13845, ISO 62304 Software Developers ➔ Develop software ➔ Maintain cadence Tooling ➔ Chores and bookkeeping ➔ Enforces workflows ➔ Acts as quality gatekeeper ➔ Traceability ➔ Generates reports on demand
16. Software development with Github flow Feature branch Development Pull request Review Quality gate Merge CompliancePal
17. Regulated software development with Github flow Feature branch Development Pull request Regulatory Review Quality gate Merge CompliancePal
18. Quality gate Familiar venue with team-wide visibility for discussing changes • Architecture evolution • Dependencies • Safety classification CompliancePal
19. CompliancePal: continuous seamless experience Git CompliancePal Developer/ Architect Compliance Officer commit notification status Team chat problems view Backlog compliance issues status CompliancePal @VladStirbu
20. Demo
21. Software development lifecycle 62304 Lean architectural design Software decomposition Continuous SOUP management Risk management 14791 Safety classification tracking Quality management 13485 Software development process CompliancePal features CompliancePal @VladStirbu
22. Ecosystem power play CompliancePal @VladStirbu Application Lifecycle Management Issue Trackers CI/CD Pipelines
23. Compliance automation benefits Developers Takes away the routine. Frees time to do more interesting and rewarding stuff. 3 Compliance Officers Better visibility. Increased capacity. 2 Management Improved quality. Reduced incidence of errors or surprises. Peace of mind. Capacity to deliver features. 1 CompliancePal @VladStirbu
24. vlad@compliancepal.eu https://compliancepal.eu